FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GAUZE, SPONGES, CAT # 11-003
K Number: K983016
·
Decision Feb 12, 1999
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
270
Applicant Total
8
Review Days
168
Basic Information
- Device Name
- GAUZE, SPONGES, CAT # 11-003
- K Number
- K983016
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VITALCARE GROUP, INC.
- Date Received
- August 28, 1998
- Decision Date
- February 12, 1999
- Product Code
- EFQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
DYNAREX TRACHEOSTOMY SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by VITALCARE GROUP, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K060109 | OMI RETRACTABLE SAFETY SYRINGE | May 5, 2006 | Substantially Equivalent |
| K050906 | VITALCARE I.V. ADMINISTRATION SET | Aug 23, 2005 | Substantially Equivalent |
| K040916 | VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE | May 4, 2005 | Substantially Equivalent |
| K031748 | VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES | Aug 27, 2003 | Substantially Equivalent |
| K992289 | VINYL POWDERED EXAM GLOVE / CAT.# 15-020 | Aug 4, 1999 | Substantially Equivalent |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | Dec 23, 1998 | Substantially Equivalent |
| K982901 | LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED | Dec 21, 1998 | Substantially Equivalent |